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MicroPort NeuroTech (Shanghai) Co., Ltd.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories1
Latest FDA decision2026-05-20
TypeNumberDevice NameCodeDateActions
510(k) K260351 Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemHCG2026-05-20 View
510(k) K242154 Numen™ Coil Embolization System; NumenFR™ Detachment SystemHCG2024-09-30 View
510(k) K232955 Numen Coil Embolization System; NumenFR Detachment SystemHCG2024-01-10 View
510(k) K203625 Numen Coil Embolization System; NumenFR Detachment SystemHCG2021-09-01 View